Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier le Mans
About this trial
In intensive care, many gastric tubes are inserted on a regular basis. There are different practices in terms of the location of the gastric tube. In some cases, the tube is inserted through the nose and in others, it is inserted through the mouth.
In the literature and in practice, these gastric tubes create discomfort and complications that have an impact not only on the patient, but also on the treatments and the length of the patient's stay in hospital.
Nosocomial Ventilator Associated Pneumonia is the most serious common complication for patients intubated with a gastric tube. It is possible that placement site may have an impact on the risk of developing Ventilator Associated Pneumonia, particularly by increasing the risk of bacterial pullulation opposite the sinuses when the tube is placed via the nasal route.
Investigator hypothesises that placing the gastric tube orally will reduce the rate of ventilator-associated pneumonia compared with the nasal route in mechanically ventilated intensive care patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient in intensive care, intubated, ventilated
Adult
Requiring a gastric tube
With an expected duration of mechanical ventilation of more than 48 hours
Disqualifiers
Pregnant, breast-feeding or parturient women
Patients under legal protection: curatorship and guardianship
Contraindication to placing a gastric tube through the nose or mouth
Patients who already have a gastric tube when they enter the service
Trial design
Design model
Crossover
Treatments tested in this trial
nasogastric tube and orogastric tube
Other interventionnasogastric tube in period 1 and orogastric tube in period 2
orogastric tube and nasogastric tube
Other interventionorogastric tube in period 1 and nasogastric tube in period 2
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: NasogastricExperimental treatment 1 intervention
Group B: OrogastricExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae
The impact is measured by the number of ventilator associated peumonia
Time frame
Day 28Secondary outcomes
1
Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol
Time frame
At gastric tube insertion or reinsertion procedure2
Pain monitoring (pain scale) during insertion or reinsertion of the gastric tube
Assessed based on the patient's neurological status : * The Visual Analog Score for pain for vigilant patients (Glasgow score greater than or equal to 12). * The algo plus scale for patients with a Glasgow score below 12 or who are unable to rate their pain. * The Behavioral Pain Scale BPS if the patient is sedated. * If the patient is curarized, there will be no pain monitoring.
Time frame
From Day 0 to Day 283
Pain monitoring (pain scale) during daily repair of the fixation system of the gastric tube
Assessed based on the patient's neurological status : * The Visual Analog Score for pain for vigilant patients (Glasgow score greater than or equal to 12). * The algo plus scale for patients with a Glasgow score below 12 or who are unable to rate their pain. * The Behavioral Pain Scale BPS if the patient is sedated. * If the patient is curarized, there will be no pain monitoring.
Time frame
From Day 0 to Day 284
Absence or presence of skin lesions qualified by location and according to the NPUAP classification of pressure ulcer stages
NPUAP classification of pressure ulcer stages : * Stage 1: erythema that does not disappear with pressure. * Stage 2: de-epidermalization (Epidermal loss). * Stade 3: necrosis. * Stage 4: Deep-tissue involvement.
Time frame
From Day 0 to Day 28Sponsors and contacts
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Source ClinicalTrials.gov